Drug product development lead

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

We don’t follow footsteps. We create the path.

The drug product development team within the technical development organization at Spark is seeking a senior experienced drug product development lead (DPD lead). This is a role in the department for someone with strong experience and can manage and handle technical, strategic, business and supervisory responsibilities independently.

Spark has paved the way for gene therapies and is a recognized leader in the transformational field. As a member of our dedicated technical development function, the lead will play a key role in leading/supporting pre-clinical, early stage clinical, late stage clinical and commercial drug product development, strategic and innovative activities for both viral vector and non-viral gene therapy drug products. This position will require project accountabilities and responsibilities on several key aspects of drug product development including formulation, process (fill-finish) and manufacturing technical transfer, container closure and device selection and development etc. The candidate may have supervisory and/or strategic and business management responsibilities. The candidate must have strong biopharmaceutical industry experience to develop, optimize, and characterize sterile-parenteral biologics drug products and is able to handle below responsibilities rather independently.

- Lead formulation development, fill-finish process development (including lyophilization process development), in use and administration and container closure and device activities

- Manage/lead analytical biophysical characterization and high throughput formulation development and screening

- Lead, represent and manage DP development on cross functional teams (e.g., analytical development, drug substance development, CMC, clinical operations, external manufacturing etc.).

- Prepare, present, represent DP as needed. Interact with senior management (including cross functional) independently

- Support external/ internal manufacturing process and participate troubleshooting and investigations

- Ensure compliance with Spark procedures and good practices (e.g., documentation)

- May supervise direct reports (experience based)

Responsibilities

% of Time

Job Function and Description

25

Lead project and manage project, strategic and innovative activities

20

Write, review and/or approve protocols, reports, guidelines, white papers, filing sections (IND/BLA), presentations and tech transfer documents

20

Meetings, preparation and presentations

20

Manage/lead lab activities (study executions, data analysis etc)

15

Hands on activities and supervision

Education and Experience Requirements

• Ph.D. in biochemistry, pharmaceutics, chemical engineering, or related discipline with 6+ years of meaningful industry experience or MS with over 9+ years of meaningful industry experience is strongly preferred. BS with 12+ years of experience is preferred

• Experience in formulation, device development, container closures, in use and administration studies, fill/finish process development for sterile large molecule parenterals i.e., gene therapies (RNA LNPs, AAVs), vaccines, cell therapies, and/or biological molecules is preferred. Strong experience on closely related sterile parenterals may be considered.

• Experience on cryopreservation is a strong plus. Good understanding of Freeze Drying/ Lyophilization of biologics is plus.

• Experience with high throughput formulation development is preferred. Experience on setting up high throughput and automation/programming platforms as they relate to biopharma development is a plus.

• Experience in large molecule analytics and biophysical characterization is strongly preferred.

- Experience of working with CMO/CRO is a strong plus

• Experience of working in a DP manufacturing setting is a plus. Experiences of large scale GMP manufacturing and GXP compliant documentation is plus

Key Skills, Abilities, and Competencies

• Strong scientific publication record and/or patent filing is plus.

• Strong organizational skills and documentation abilities is required.

• Should be adaptable/flexible and able to work independently and in teams as needed

• Strong writing and verbal communication skills is required

• Demonstrate independent problem-solving skills of technical issues

Complexity and Problem Solving

• Work to establish best practices.
• Mentor and advise other scientists to effectively leverage tools
• Leverage tools to solve difficult technical challenges as a member on technical or project teams

Internal and External Contacts

• Fellow team members to develop new strategies and capabilities
• Cross functional team members
• CROs and CMOs

Other Job Requirements

• Must be able to lift 25 pounds
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location.  Accommodations may be made in accordance with applicable law.